Cytomegalovirus vaccine

A Cytomegalovirus vaccine is a vaccine to prevent cytomegalovirus (CMV) infection or to prevent it re-activation in those who are already infected. As of 2014 no such a vaccine exists, although a number of vaccine candidates are under investigation. They include recombinant protein, live attenuated, DNA and other vaccines.[1][2]

As a member of the TORCH complex, cytomegalovirus can cause congenital infection, which can lead to neurological problems, vision and hearing loss. Infection/re-activation of CMV in immuno-compromised persons, including organ transplantation recipients, causes significant mortality and morbidity. Additionally, CMV has strong associations with plaques found in atherosclerosis progression.[3] Because of all these, there has been considerable effort made towards the development of a vaccine, with particular emphasis on protection of pregnant women.[4] Since vaccination of the immunocompromised persons introduces additional challenges, members of this population are less likely to be candidates for such a vaccine.[1][5]

Development of such a vaccine has been emphasized as a priority by the National Vaccine Program Office in the United States.[6][7]

Recombinant gB subunit vaccine

A phase 2 study of a recombinant gB subunit CMV-vaccine published in 2009 indicated an efficacy of 50% in seronegative women of childbearing age—thus the protection provided was limited and a number of subjects contracted CMV infection despite the vaccination. In one case congenital CMV was encountered.[1][8]

Another phase 2 study of the same vaccine was done in patients awaiting kidney transplantation. The vaccine significantly boosted the antibody levels and reduced the duration of post-transplantation viremia.[1]

Further research

In 2013, Astellas Pharma has started on individuals who received a hematopoietic stem cell transplant a Phase III trial with its CMV deoxyribonucleic acid DNA cytomegalovirus vaccine ASP0113.[9]

In 2015, Astellas Pharma has commenced on healthy volunteers a Phase I trial with its cytomegalovirus vaccine ASP0113.[10]

In 2016, VBI Vaccines commenced a Phase I preventative cytomegalovirus vaccine study (VBI-1501). [11]

Other cytomegalovirus vaccines candidates are the CMV-MVA Triplex vaccine and the CMVpp65-A*0201 peptide vaccine. Both vaccine candidates are sponsored by the City of Hope National Medical Center. As of 2016, the development is in clinical phase 2 trial stage.[12][13]

References

  1. 1 2 3 4 Dasari, V.; Smith, C.; Khanna, R. (2013). "Recent advances in designing an effective vaccine to prevent cytomegalovirus-associated clinical diseases". Expert Review of Vaccines. 12 (6): 661. PMID 23750795. doi:10.1586/ERV.13.46.
  2. ↑ Zhong J, Rist M, Cooper L, Smith C, Khanna R (2008). "Induction of pluripotent protective immunity following immunisation with a chimeric vaccine against human cytomegalovirus". PLoS ONE. 3 (9): e3256. PMC 2533118 Freely accessible. PMID 18806877. doi:10.1371/journal.pone.0003256.
  3. ↑ https://books.google.com/books?id=0ToGnkORSAMC&pg=PA25&lpg=PA25
  4. ↑ Schleiss MR (March 2008). "Comparison of vaccine strategies against congenital CMV infection in the guinea pig model". J. Clin. Virol. 41 (3): 224–30. PMID 18060834. doi:10.1016/j.jcv.2007.10.008.
  5. ↑ Schleiss MR, Heineman TC (June 2005). "Progress toward an elusive goal: current status of cytomegalovirus vaccines". Expert Rev Vaccines. 4 (3): 381–406. PMID 16026251. doi:10.1586/14760584.4.3.381.
  6. ↑ Khanna R, Diamond DJ (January 2006). "Human cytomegalovirus vaccine: time to look for alternative options". Trends Mol Med. 12 (1): 26–33. PMID 16337831. doi:10.1016/j.molmed.2005.11.006.
  7. ↑ Arvin AM, Fast P, Myers M, Plotkin S, Rabinovich R (July 2004). "Vaccine development to prevent cytomegalovirus disease: report from the National Vaccine Advisory Committee". Clin. Infect. Dis. 39 (2): 233–9. PMID 15307033. doi:10.1086/421999.
  8. ↑ Pass RF, Zhang C, Evans A, et al. (2009). "Vaccine prevention of maternal cytomegalovirus infection". N Engl J Med. 360 (12): 1191–9. PMC 2753425 Freely accessible. PMID 19297572. doi:10.1056/NEJMoa0804749.
  9. ↑ "A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT) (HELIOS)". ClinicalTrials.gov. 2013-06-12. Retrieved 2015-10-26.
  10. ↑ "An Evaluation of a Cytomegalovirus (CMV) Vaccine (ASP0113) in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients". ClinicalTrials.gov. 2015-07-08. Retrieved 2015-10-22.
  11. ↑ "Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 18 September 2016.
  12. ↑ "Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant". ClinicalTrials.gov. 2015-07-21. Retrieved 2016-01-23.
  13. ↑ "Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant". ClinicalTrials.gov. 2015-03-12. Retrieved 2016-01-23.
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